FDA WARNING_LETTER - Gabrimar Export Fish, S.A. - July 28, 2011

An FDA inspection of Gabrimar Export Fish, S.A. in Panama City, Panama, on July 27-28, 2011, revealed serious deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, 21 CFR Part 123. The firm received an FDA-483, but no response was submitted. These failures render the firm's fishery products, including Fresh, Whole Mahi Mahi HG, adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. Key violations include the absence of appropriate critical limits in the HACCP plan for controlling histamine in scombrotoxin-forming species at receipt and an inappropriate critical limit for ciguatera fish poisoning (CFP) containing fish, as required by 21 CFR 123.6(c)(3). Additionally, the corrective action plan for scombrotoxin-forming fish at the storage critical control point was deemed inappropriate, as evaluation based on time and temperature cannot be determined without continuous monitoring, violating 21 CFR 123.7(b). The firm must respond within fifteen working days, detailing corrective actions, including revised HACCP plans and monitoring records. Failure to comply may result in refusal of admission of products into the U.S. and detention without physical examination (DWPE).